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A Randomized, Double-Blind, Dose-Finding, Multicenter, Phase 2 Study of Radium Chloride (Ra 223) in Patients with Bone Metastases and Castration-Resistant Prostate Cancer

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  • Background: Patients With Castration-Resistant Prostate Cancer (Crpc) And Bone Metastases Have An Un
  • Objective: To Prospectively Evaluate The Efficacy And Safety Of Three Different Doses Of Radium Chlo
  • Design
  • Setting
  • And Participants: In This Phase 2 Double-Blind Multicenter Study
  • 122 Patients Were Randomized To Receive Three Injections Of Ra 223 At 6-Wk Intervals
  • At Doses Of 25 Kbq/Kg (N=41)
  • 50 Kbq/Kg (N=39)
  • Or 80 Kbq/Kg (N=42)
  • The Study Compared The Proportion Of Patients In Each Dose Group Who Had A Confirmed Decrease Of =50
  • Outcome Measurements And Statistical Analysis: Efficacy Was Evaluated Using Blood Samples To Measure
  • Recorded Skeletal-Related Events
  • And Pain Assessments
  • Safety Was Evaluated Using Adverse Events (Aes)
  • Physical Examination
  • And Clinical Laboratory Tests
  • The Jonckheere-Terpstra Test Assessed Trends Between Groups
  • Results And Limitations: The Study Met Its Primary End Point With A Statistically Significant Dose-R
  • Two Patients (6%) In The 50-Kbq/Kg Dose Group
  • And Five Patients (13%) In The 80-Kbq/Kg Dose Group (P=0
  • 0297)
  • A =50% Decrease In Bone Alkaline Phosphatase Levels Was Identified In Six Patients (16%)
  • 24 Patients (67%)
  • And 25 Patients (66%) In The 25-
  • 50-
  • And 80-Kbq/Kg Dose Groups
  • Respectively (P

Abstract

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